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Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

2014-07-24 14:06:54 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of F2695 sustained release (SR) relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Description

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with F2695 SR are randomized to continue F2695 SR or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Depression

Intervention

F2695 SR, Placebo

Location

Forest Investigative Site #023
Beverly Hills
California
United States
90210

Status

Recruiting

Source

Forest Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:06:54-0400

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Medical and Biotech [MESH] Definitions

Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.

Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)

Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.

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